INDICATION(S):

Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS).

Nucynta ER Approved for Chronic Pain

NUCYNTA ER (tapentadol) 50mg, 100mg, 150mg, 200mg, 250mg extended-release tablets by Janssen




Nucynta ER (tapentadol extended-release) tablets for the management of moderate-to-severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. This approval was based on data from Phase 3, double-blind, randomized, active- and/or placebo-controlled studies demonstrating efficacy and safety, a favorable tolerability profile and favorable discontinuation rates.

Nucynta ER, a centrally acting synthetic analgesic, is a C-II controlled substance. It is expected to be available the last week of August 2011 in 50mg, 100mg, 150mg, 200mg and 250mg strengths.







 

GRALISE (gabapentin) 300mg and 600mg tablets by Depomed




Gralise (gabapentin tablets) for the treatment of postherpetic neuralgia (PHN). Gralise utilizes a proprietary patented polymer technology to gradually release the drug and is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

Gralise is available in 300mg and 600mg dosage strength tablets.







Vyvanse




 

Class
CNS stimulant
 
Indication
Attention deficit hyperactivity disorder (ADHD)
 
Active Ingredient
Lisdexamfetamine dimesylate 30mg, 50mg, 70mg; caps.



 



zicronapine  


Zicronapine is a dopamine D₁, D₂ and 5-HT_2A receptor antagonist. The compound is in clinical phase III development for the potential treatment of patients with schizophrenia.




pomaglumetad methionil  


LY 2140023 is a potent and systemically active metabotropic glutamate mGluR_2/3 agonist in development for the treatment of schizophrenia. The compound has been evaluated in schizophrenic patients in a phase II trial. Treatment with LY 2140023 was safe and well-tolerated, and the patients showed significant improvements in both positive and negative symptoms of schizophrenia compared to placebo. Patients treated with the compound did not differ from placebo-treated patients with respect to prolactin elevation, extrapyramidal symptoms or weight gain. By April 2011, phase III trials had been initiated.



amitifadine

Amitifadine hydrochloride is a 5-HT, NA and DA reuptake inhibitor. It demonstrates greatest affinity for the 5-HT transporter, is half as potent for NA and one-eights the potency for the DA transporter resulting in a ratio of 1:2:8. Amitifadine is in development for the potential treatment of major depressive disorder (MDD) and obesity. In March 2011, a phase IIb/IIIa trial began.



edivoxetine

Edivoxetine is an oral second-generation noradrenaline (NA) reuptake inhibitor in development for the potential treatment of major depressive disorder (MDD) and attention deficit hyperactivity disorder (ADHD). In June 2009, a phase II/III ADHD trial began, and in July 2010, phase III MDD trials were initiated.



vortioxetine   Lu AA21004

Vortioxetine (Lu AA21004), a bis-aryl-sulphanyl amine compound, is a serotonin modulator with 5-HT_1A agonist, 5-HT₃, 5-HT₇ and 5-HT_1B antagonist and 5-HT reuptake inhibitory activity in clinical phase III development for the potential treatment of major depression and generalised anxiety disorder (GAD).

 

 

ZYPREXA RELPREVV

ZYPREXA RELPREVV is a long-acting form of olanzapine and is intended for deep intramuscular gluteal injection only.

ZYPREXA RELPREVV includes a vial of the drug product and a vial of the sterile diluent for ZYPREXA RELPREVV. The drug product is olanzapine pamoate monohydrate, present as a yellow solid in a glass vial equivalent to 210, 300, or 405 mg olanzapine base per vial. The diluent for ZYPREXA RELPREVV is a clear, colorless to slightly yellow solution in a glass vial and is composed of carboxymethylcellulose sodium, mannitol, polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. The drug product is suspended in the diluent for ZYPREXA RELPREVV to a target concentration of 150 mg olanzapine per mL prior to intramuscular injection

ZYPADHERA

 

 

LATUDA

Pharmacological Class:

Atypical antipsychotic (benzisothiazol derivative).

Active Ingredient(s):

Lurasidone 40mg, 80mg; tabs.

Indication(s):

Schizophrenia.

Pharmacology:

The mechanism of action of lurasidone, as with other drugs having efficacy in schizophrenia, is unknown. It has been suggested that the efficacy of lurasidone in schizophrenia is mediated through a combination of central dopamine Type 2 (D₂) and serotonin Type 2 (5HT_2A) receptor antagonism.

Clinical Trials:

The efficacy of lurasidone was established in 4 short-term (6-week), placebo-controlled studies in adults who met DSM-IV criteria for schizophrenia. One study included an active-control arm (olanzapine) to assess assay sensitivity. The Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale derived (BPRSd), and Clinical Global Impression severity scale (CGI-S) were used for assessing psychiatric signs and symptoms. The endpoint associated with each instrument was change from baseline in the total score to the end of Week 6.

In a 6-week, placebo-controlled trial involving two fixed doses of lurasidone (40 or 120mg/day), both doses of lurasidone at endpoint were superior to placebo on the BPRSd total score, and the CGI-S, as was lurasidone 80mg/day in another 6-week placebo-controlled trial.

In a 6-week, placebo and active-controlled trial involving two fixed doses of lurasidone (40 or 120mg/day) and an active control (olanzapine), both lurasidone doses and the active control at endpoint were superior to placebo on the PANSS total score, and the CGI-S.

In a 6-week, placebo-controlled trial involving three fixed doses of lurasidone (40, 80 or 120mg/day), only the 80mg/day dose of lurasidone at endpoint was superior to placebo on the PANSS total score, and the CGI-S.

Thus, the efficacy of lurasidone at doses of 40, 80 and 120mg/day was established in two studies for each dose. However, the 120mg dose did not appear to add additional benefit over the 40mg dose.

Legal Classification:

Rx

Adults:

Take with food (≥350 calories). 40mg once daily. Max 80mg/day. Moderate to severe renal or hepatic impairment, concomitant moderate CYP3A4 inhibitors: max 40mg/day.